US12427247B2 - Stopcock apparatus for angiography injector fluid paths - Google Patents

Stopcock apparatus for angiography injector fluid paths

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Publication number
US12427247B2
US12427247B2 US17/801,975 US202117801975A US12427247B2 US 12427247 B2 US12427247 B2 US 12427247B2 US 202117801975 A US202117801975 A US 202117801975A US 12427247 B2 US12427247 B2 US 12427247B2
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port
fluid
valve
fluid path
valve assembly
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US17/801,975
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US20230139275A1 (en
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Kevin Cowan
James Dedig
John Haury
Patrick Campbell
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Bayer Healthcare LLC
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Bayer Healthcare LLC
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Publication of US20230139275A1 publication Critical patent/US20230139275A1/en
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142—Pressure infusion, e.g. using pumps
    • A61M5/145—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons
    • A61M5/1452—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons pressurised by means of pistons
    • A61M5/14546—Front-loading type injectors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/22—Valves or arrangement of valves
    • A61M39/223—Multiway valves
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/168—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body
    • A61M5/16804—Flow controllers
    • A61M5/16822—Flow controllers by controlling air intake into infusion reservoir
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/36—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests with means for eliminating or preventing injection or infusion of air into body
    • A61M5/365—Air detectors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142—Pressure infusion, e.g. using pumps
    • A61M5/145—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons
    • A61M5/1452—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons pressurised by means of pistons
    • A61M5/14546—Front-loading type injectors
    • A61M2005/14553—Front-loading type injectors comprising a pressure jacket
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/162—Needle sets, i.e. connections by puncture between reservoir and tube ; Connections between reservoir and tube
    • A61M2005/1623—Details of air intake
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/22—Valves or arrangement of valves
    • A61M2039/229—Stopcocks

Definitions

  • the present disclosure relates generally to fluid path configurations and apparatuses for use with angiography fluid injectors for high pressure injection of medical fluids. More specifically, the present disclosure describes a fluid delivery system having a valve assembly configured to minimize potential administration of air to a patient during an injection procedure.
  • a medical practitioner such as a physician injects a patient with one or more medical fluids.
  • medical fluids such as a contrast solution (often referred to simply as “contrast”), a flushing agent (such as saline or Ringer's lactate), and other medical fluids
  • CV cardiovascular angiography
  • CT computed tomography
  • MRI magnetic resonance imaging
  • PET positron emission tomography
  • these fluid injectors are designed to deliver a preset amount of fluid at a preset pressure and/or flow rate.
  • fluid injectors have at least one drive member, such as a piston, that connects to the syringe, for example via connection with a plunger or an engagement feature on a proximal end wall of the syringe.
  • the syringe may include a rigid barrel with the syringe plunger being slidably disposed within the barrel.
  • the drive members drive the plungers in a proximal and/or distal direction relative to a longitudinal axis of the barrel to draw fluid into or deliver the fluid from the syringe barrel.
  • the medical fluids are injected directly into the cardiac system at fluid pressures up to 1200 psi.
  • Embodiments of the present disclosure are directed to a valve assembly for a fluid injector system
  • the valve assembly includes a valve housing, a first port configured for fluid communication with at least one syringe of a fluid injector, a second port, a third port, and a fourth port configured for fluid communication with a patient line.
  • the valve assembly further includes an air detection region associated with the first port, a fluid path length fluid path length having a proximal end in fluid communication with the second port and a distal end in fluid communication with the third port, and a valve element defining a first valve fluid path and a second valve fluid path.
  • the first valve fluid path provides fluid communication between the first port and the second port when in a delivery position of the valve housing relative to the valve element.
  • the second valve fluid path provides fluid communication between the third port and the fourth port when in the delivery position.
  • the third port is isolated from the fourth port when in a stop position of the valve housing relative to the valve element.
  • thee valve assembly further includes a fifth port configured for fluid communication with a bulk fluid source.
  • the first fluid path provides fluid communication between the first port and the fifth port when in a fill position of the valve housing relative to the valve element.
  • the fluid path length includes tubing having a length greater than a distance that an air bubble can travel or expand during an actuation time of the valve assembly.
  • the actuation time of the valve assembly is a time interval between a time at which the air bubble is detected in the air detection region and a time at which the valve assembly reaches the stop position.
  • the first port, the second port, the third port, and the fourth port are arranged circumferentially about the valve housing.
  • valve element is rotatable about a longitudinal axis of the valve housing between the delivery position and the stop position.
  • the first port is offset relative to the second port along a longitudinal axis of the valve housing.
  • the first port is integrally formed with the valve element and in fluid communication with the first valve fluid path.
  • valve housing is slidable relative to the valve element between the delivery position and the stop position.
  • At least portions of the first valve fluid path and the second valve fluid path extend parallel to a longitudinal axis of the valve housing.
  • fluid path length includes a plurality of longitudinal fluid channels arranged circumferentially about the valve housing, and a plurality of bent fluid channels connecting the plurality of longitudinal fluid channels in series.
  • the fluid path length includes coiled tubing.
  • a fluid delivery system including at least one powered injector, at least one syringe, at least one air detector, a valve assembly, at least one controller in electrical communication with the at least one air detector.
  • the at least one controller is configured for controlling fluid flow through the valve assembly.
  • the fluid injector system further includes a patient line.
  • the valve assembly includes a valve housing, a first port in fluid communication with the at least one powered injector, a second port, a third port, and a fourth port, a fluid path length having a proximal end in fluid communication with the second port and a distal end in fluid communication with the third port, and a valve element defining a first valve fluid path and a second valve fluid path.
  • the fluid delivery system further includes a bulk fluid source
  • the valve assembly further includes a fifth port in fluid communication with the bulk fluid source
  • the first valve fluid path provides fluid communication between the first port and the fifth port when in a fill position of the valve housing relative to the valve element.
  • the fluid path length includes tubing having a length greater than a distance that an air bubble can travel or expand during an actuation time of the valve assembly.
  • the actuation time of the valve assembly is a time interval between a time at which the air bubble is detected in the air detection region and a time at which the valve assembly reaches the stop position.
  • first port, the second port, the third port, and the fourth port are arranged circumferentially about the valve housing
  • valve element is rotatable about a longitudinal axis of the valve housing between the delivery position and the stop position.
  • the first port is offset relative to the second port along a longitudinal axis of the valve housing.
  • the first port is integrally formed with the valve element and in fluid communication with the first valve fluid path.
  • At least portions of the first valve fluid path and the second valve fluid path extend parallel to a longitudinal axis of the valve housing.
  • the fluid path length includes a plurality of longitudinal fluid channels arranged circumferentially about the valve housing, and a plurality of bent fluid channels connecting the plurality of longitudinal fluid channels in series.
  • the fluid path length includes coiled tubing.
  • inventions of the present disclosure are directed to a method of trapping an air bubble in a fluid path length during an injection procedure performed by a fluid delivery system.
  • the method includes detecting an air bubble flowing distally from at least one syringe and into a valve assembly with at least one air detector, the valve assembly including a including a first port, a second port, a third port, and a fourth port.
  • the method further includes actuating the valve assembly to isolate the third port from the fourth port, thereby trapping the air bubble in the fluid path length between the second port and the third port. Actuating the valve assembly occurs within 60 and 100 milliseconds after detecting the air bubble with the air detector.
  • the fluid path length includes tubing having a length greater than a distance that the air bubble can travel or expand during an actuation time of the valve assembly.
  • the actuation time of the valve assembly is a time interval between a time at which the air bubble is detected and a time at which the third port is isolated from the fourth port.
  • actuating the valve assembly includes rotating a valve element of the valve assembly relative to a valve housing of the valve assembly.
  • actuating the valve assembly includes sliding the valve housing of the valve assembly relative to the valve element of the valve assembly.
  • the fluid path length includes tubing have a length of between approximately 1000 millimeters and approximately 1400 millimeters.
  • the valve assembly includes a valve housing.
  • the first port, the second port, the third port, and the fourth port are arranged circumferentially about the valve housing.
  • the valve assembly includes a valve element rotatable about a longitudinal axis of the valve housing between the delivery position and the stop position.
  • the first port is offset relative to the second port along a longitudinal axis of the valve housing.
  • the first port is integrally formed with the valve element.
  • valve housing is slidable relative to the valve element between the delivery position and the stop position.
  • the valve element includes a first valve fluid path and a second valve fluid path. At least portions of the first fluid path and the second fluid path extend parallel to a longitudinal axis of the valve housing.
  • the fluid path length includes a plurality of longitudinal fluid channels arranged circumferentially about the valve housing, and a plurality of bent fluid channels connecting the plurality of longitudinal fluid channels in series.
  • the fluid path length includes coiled tubing.
  • a valve assembly for a fluid injector system comprising: a valve housing; a first port configured for fluid communication with at least one syringe of a fluid injector, a second port, a third port, and a fourth port configured for fluid communication with a patient line; an air detection region associated with the first port; a fluid path length having a proximal end in fluid communication with the second port and a distal end in fluid communication with the third port; and a valve element defining a first valve fluid path and a second valve fluid path, wherein the first valve fluid path provides fluid communication between the first port and the second port when in a delivery position of the valve housing relative to the valve element, wherein the second valve fluid path provides fluid communication between the third port and the fourth port when in the delivery position, and wherein the third port is isolated from the fourth port when in a stop position of the valve housing relative to the valve element.
  • valve assembly of clause 1 further comprising a fifth port configured for fluid communication with a bulk fluid source, wherein the first fluid path provides fluid communication between the first port and the fifth port when in a fill position of the valve housing relative to the valve element.
  • Clause 7 The valve assembly of any of clauses 1 to 6, wherein the first port is offset relative to the second port along a longitudinal axis of the valve housing.
  • Clause 11 The valve assembly of any of clauses 1 to 10, wherein the fluid path length comprises: a plurality of longitudinal fluid channels arranged circumferentially about the valve housing; and a plurality of bent fluid channels connecting the plurality of longitudinal fluid channels in series.
  • a fluid delivery system comprising: at least one powered injector; at least one syringe; at least one air detector; a valve assembly; at least one controller in electrical communication with the at least one air detector, wherein the at least one controller is configured for controlling fluid flow through the valve assembly; and a patient line
  • the valve assembly comprises: a valve housing; a first port in fluid communication with the at least one powered injector, a second port, a third port, and a fourth port; a fluid path length having a proximal end in fluid communication with the second port and a distal end in fluid communication with the third port; and a valve element defining a first valve fluid path and a second valve fluid path; and wherein the patient line is in fluid communication with the fourth port, wherein the first valve fluid path provides fluid communication between the first port and the second port in a delivery position of the valve housing relative to the valve element, wherein the second valve fluid path provides fluid communication between the third port and the fourth port in the delivery position, and wherein the third port is isolated from
  • Clause 14 The fluid delivery system of clause 13, further comprising: an actuator operably associated with the air detector and configured to transition the valve assembly to the stop position upon detection of air bubble by the air detector, wherein the air detector is upstream of or within the first port and configured to detect an air bubble flowing out of the at least one syringe.
  • Clause 15 The fluid delivery system of clause 13 or 14, wherein the fluid path length comprises tubing having a length greater than a distance that the air bubble can travel or expand during an actuation time of the valve assembly, wherein the actuation time of the valve assembly is a time interval between a time at which the air bubble is detected by the air detector and a time at which the valve assembly reaches the stop position.
  • Clause 16 The fluid delivery system of any of clauses 13 to 15, further comprising a bulk fluid source, wherein the valve assembly further comprises a fifth port in fluid communication with the bulk fluid source, and wherein the first valve fluid path provides fluid communication between the first port and the fifth port when in a fill position of the valve housing relative to the valve element.
  • Clause 18 The fluid delivery system of any of clauses 13 to 17, wherein the fluid path length comprises tubing have a length of between approximately 1000 millimeters and approximately 1400 millimeters.
  • Clause 21 The fluid delivery system of any of clauses 13 to 20, wherein the first port is offset relative to the second port along a longitudinal axis of the valve housing.
  • Clause 22 The fluid delivery system of any of clauses 13 to 21, where the first port is integrally formed with the valve element and in fluid communication with the first valve fluid path.
  • Clause 25 The fluid delivery system of any of clauses 13 to 24, wherein the fluid path length comprises: a plurality of longitudinal fluid channels arranged circumferentially about the valve housing; and a plurality of bent fluid channels connecting the plurality of longitudinal fluid channels in series.
  • Clause 26 The fluid delivery system of any of clauses 13 to 25, wherein the fluid path length comprises coiled tubing.
  • a method of trapping an air bubble in a fluid path length during an injection procedure performed by a fluid delivery system comprising: detecting an air bubble flowing distally from at least one syringe and into a valve assembly with at least one air detector, the valve assembly comprising a comprising a first port, a second port, a third port, and a fourth port; and actuating the valve assembly to isolate the third port from the fourth port, thereby trapping the air bubble in the fluid path length between the second port and the third port, wherein actuating the valve assembly occurs within 60 and 100 milliseconds after detecting the air bubble with the air detector.
  • Clause 31 The method of any of clauses 27 to 30, wherein the fluid path length comprises tubing have a length of between approximately 1000 millimeters and approximately 1400 millimeters.
  • valve assembly comprises a valve element rotatable about a longitudinal axis of the valve housing between the delivery position and the stop position.
  • Clause 34 The method of any of clauses 27 to 33, wherein the first port is offset relative to the second port along a longitudinal axis of the valve housing.
  • valve element comprises a first valve fluid path and a second valve fluid path, and wherein at least portions of the first fluid path and the second fluid path extend parallel to a longitudinal axis of the valve housing.
  • Clause 38 The method of any of clauses 27 to 37, wherein the fluid path length comprises: a plurality of longitudinal fluid channels arranged circumferentially about the valve housing; and a plurality of bent fluid channels connecting the plurality of longitudinal fluid channels in series.
  • Clause 39 The method of any of clauses 27 to 38, wherein the fluid path length comprises coiled tubing.
  • FIG. 1 is a perspective view of a fluid delivery system according to an embodiment of the present disclosure
  • FIG. 2 is a schematic view of a fluid delivery system in accordance with an embodiment of the present disclosure, with a valve assembly thereof in a delivery position;
  • FIG. 3 is a schematic view of the fluid delivery system of FIG. 2 , with the valve assembly in a stop position;
  • FIG. 4 is a schematic view of the fluid delivery system in accordance with an embodiment of the present disclosure, with a valve assembly thereof in a fill position;
  • FIG. 5 is a schematic view of the fluid delivery system of FIG. 4 , with the valve assembly in a delivery position;
  • FIG. 6 is a schematic view of the fluid delivery system of FIG. 4 , with the valve assembly in a stop position;
  • FIG. 7 is a perspective view of a fluid delivery system including a valve assembly according to an embodiment of the present disclosure, with the valve assembly shown in a fill position;
  • FIG. 10 is a bottom side perspective view of the valve assembly of FIG. 9 ;
  • FIG. 11 is a top view of the valve assembly of FIG. 9 ;
  • FIG. 12 is a side view of the valve assembly of FIG. 9 ;
  • FIG. 13 is a bottom view of the valve assembly of FIG. 9 ;
  • FIG. 14 is a cross-sectional top view of the valve assembly of FIG. 12 along line A-A;
  • FIG. 16 is a cross-sectional bottom view of the valve assembly of FIG. 12 along line B-B;
  • FIG. 18 is a cross-sectional side view of the fluid delivery system of FIG. 17 , with the valve assembly in the fill position;
  • FIG. 19 is a cross-sectional top view of the fluid delivery system of FIG. 17 , with the valve assembly in an intermediate stop position;
  • FIG. 20 is a cross-sectional side view of the fluid delivery system of FIG. 17 , with the valve assembly in a delivery position;
  • FIG. 21 is a cross-sectional top view of the fluid delivery system of FIG. 20 , with the valve assembly in the delivery position;
  • FIG. 22 is a cross-sectional side view of the fluid delivery system of FIG. 17 , with the valve assembly in a full stop position;
  • FIG. 25 is a distal end view of the valve assembly of FIG. 24 ;
  • FIG. 26 is a cross-sectional side view of the valve assembly of FIG. 25 along line C-C;
  • FIG. 27 is a perspective view of a fluid delivery system including a valve assembly according to an embodiment of the present disclosure
  • FIG. 28 is a cross-sectional side view of the fluid delivery system of FIG. 27 ;
  • FIG. 29 is a cross-sectional side view of a fluid delivery system including a valve assembly according to an embodiment of the present disclosure.
  • the present disclosure is generally directed to an in-line air bubble suspension apparatus for use with an angiography injector system.
  • the term “at least one of” is synonymous with “one or more of”.
  • the phrase “at least one of A, B, and C” means any one of A, B, and C, or any combination of any two or more of A, B, and C.
  • “at least one of A, B, and C” includes one or more of A alone; or one or more B alone; or one or more of C alone; or one or more of A and one or more of B; or one or more of A and one or more of C; or one or more of B and one or more of C; or one or more of all of A, B, and C.
  • the term “at least two of” is synonymous with “two or more of”.
  • the phrase “at least two of D, E, and F” means any combination of any two or more of D, E, and F.
  • “at least two of D, E, and F” includes one or more of D and one or more of E; or one or more of D and one or more of F; or one or more of E and one or more of F; or one or more of all of D, E, and F.
  • distal refers to a portion of said component nearest to a patient.
  • proximal refers to a portion of said component nearest to the injector of the fluid injector system (i.e. the portion of said component farthest from the patient).
  • the term “upstream” refers to a direction away from the patient and towards the injector of the fluid injector system. For example, if a first component is referred to as being “upstream” of a second component, the first component is located nearer to the injector than the second component is to the injector.
  • the term “downstream” refers to a direction towards the patient and away from the injector of the fluid delivery system. For example, if a first component is referred to as being “downstream” of a second component, the first component is located nearer to the patient than the second component is to the patient.
  • Capacitance and “impedance” are used interchangeably to refer to a volumetric expansion of injector components, such as fluid reservoirs, syringes, fluid lines, and/or other components of a fluid delivery system as a result of pressurized fluids with such components and/or uptake of mechanical slack by force applied to components.
  • Capacitance and impedance may be due to high injection pressures, which may be on the order of 1200 psi in some angiographic procedures, and may result in a volume of fluid held within a portion of a component in excess of the desired quantity selected for the injection procedure or the resting volume of the component. Additionally, capacitance of various components can, if not properly accounted for, adversely affect the accuracy of pressure sensors of the fluid injector system because the volumetric expansion of components can cause an artificial drop in measured pressure of those components.
  • the fluid delivery system 1000 may include an injector housing 11 having two syringe ports 15 configured to engage two syringes 12 .
  • the syringes 12 may be retained within corresponding pressure jackets for example to prevent pressure-induced swelling and potential bursting of the syringes 12 .
  • the at least one air detector 200 may include an ultrasonic sensor, optical sensor, or the like, configured to detect one or more air bubbles within the fluid paths.
  • the fluid path length 135 is tubing having a length and associated fluid volume greater than a volume distance than an air bubble can travel or expand during the actuation time taken for the valve assembly 100 to transition from the delivery position to the stop position.
  • the tubing of the fluid path length 135 may be between approximately 1000 millimeters and approximately 1400 millimeters (or between approximately 3.5 feet and approximately 4.5 feet) long.
  • the tubing of the fluid path length 135 may be approximately 1200 millimeters (or approximately 4 feet) long.
  • the tubing of the fluid path length 135 may be coiled or wrapped to reduce the size of the fluid path length 135 and to prevent entanglement of the tubing with other components and individuals present in an injection room.
  • the total actuation time to stop an injection procedure may include time detecting an air bubble by the air detector 200 ; time communicating to the controller 400 that an air bubble has been detected; time for the controller 400 instructing the actuator 300 to rotate the five-way high pressure stopcock 110 to a stop position; and time until the patient line 55 is fully isolated from the fluid path length 135 to prevent continued fluid flow from one or more of rapid flow rate, compliance release (i.e., volume relaxation of pressure swollen syringe and fluid path components and release of up-taken mechanical slack in the fluid injector), and/or bubble expansion due to pressure lowering, so as to prevent the air bubble from continuing into the patient.
  • compliance release i.e., volume relaxation of pressure swollen syringe and fluid path components and release of up-taken mechanical slack in the fluid injector
  • bubble expansion due to pressure lowering so as to prevent the air bubble from continuing into the patient.
  • the fluid delivery system 1000 may at least temporarily contain the detected air bubble(s) in the fluid path length 135 and prevent the trapped air from being injected into the patient when actuated to the stop position.
  • the fluid injection procedure may be halted upon moving the five-way high pressure stopcock 110 to the stop position and typically the fluid injection and imaging procedure must be rescheduled or reinitiated from the start.
  • the stop position may be any rotary position of the valve element 140 where the fourth port 40 and the patient line 55 are fluidly isolated from (i.e. not in fluid communication with) either the first fluid path 150 or the second fluid path 160 or both. Because of the relative positions of the first fluid path 150 and the second fluid path 160 of the valve element 140 relative to the fourth port 40 , only minor rotational actuation of engagement feature 170 may be required to move the five-way high pressure stopcock 110 from the delivery position to the stop position. For example, the valve element 140 may only need to be rotated so that the second fluid path 160 , which is in fluid communication with the fourth port 40 in the delivery position, interfaces with an inner wall 132 of the valve housing 130 not occupied by the fourth port 40 .
  • pre-pressurization of a medical fluid in syringe 12 may provide smoother pressure/flow transitions when switching between injection of a more viscous medical fluid and a less viscous medical fluid, such as contrast and saline, respectively.
  • a more viscous medical fluid such as contrast and saline
  • a less viscous medical fluid such as contrast and saline
  • injection protocols using pre-pressurization to prevent fluid flow spikes during fluid transitions are described in International PCT Publication Nos. WO 2019/046260 and WO 2019/046259, the disclosures of which are hereby incorporated by reference in their entireties.
  • the intermediate stop position may allow for detection of air within the fluid delivery system 1000 by pressurization of the syringe 12 contents prior to the injection procedure, as described in International PCT Publication No.
  • the intermediate stop position may allow for vacuum coalescence and purging of air bubbles from the syringe system prior to the injection protocol, as described in International PCT Publication No. WO 2019/204617, the disclosure of which is hereby incorporated by reference in its entirety.
  • FIGS. 7 and 8 show the fluid path length 135 as a coiled length of tubing
  • the fluid path length 135 may be any of the various embodiments discussed herein with reference to FIGS. 2 - 6 .
  • the fluid path length 135 may include a length of tubing such as between approximately 1000 and approximately 1400 millimeters, or a length of tubing or approximately 1200 millimeters (or between approximately 3.5 feet and approximately 4.5 feet, or a length of tubing of approximately 4 feet). In some embodiments, such as shown in FIGS.
  • valve housing 130 may be rotatably and sealably engaged with the valve element 140 , such that fluid even under the high pressure a CV injections cannot flow between the valve housing 130 and the valve element 140 except through the ports 10 , 20 , 30 , 40 , 50 and the fluid paths 150 , 160 .
  • FIGS. 9 to 16 various views of the five-way high pressure stopcock 110 are provided according to specific embodiments of the present disclosure to more readily illustrate the various fluid flow paths described herein and the interconnectedness of the various ports in different configurations and positions.
  • the valve housing 130 may be rotatably and sealably engaged with the valve element 140 , such that fluid even under the high pressure a CV injections cannot flow between the valve housing 130 and the valve element 140 except through the ports 10 , 20 , 30 , 40 , 50 and the fluid paths 150 , 160 .
  • fluid communication between the first port 10 and the fifth port 50 is provided by the second fluid path 160 in the plane between the first port 10 and the fifth port 50 .
  • fluid communication is blocked between the third port 30 and the fourth port 40 by the diagonal nature of the first fluid path 150 which does not interconnect the co-planar third port 30 and fourth port 40 . Instead, the distal end of the first fluid path 150 abuts an inner wall 132 of valve housing 130 (see FIG. 4 ).
  • FIG. 14 illustrates a cross-sectional top view of the five-way high pressure stopcock 110 along line A-A of FIG. 12 .
  • the first fluid path 150 provides fluid communication between the first port 10 and the second port 20 .
  • the second fluid path 160 (shown in dashed lines as the second fluid path 160 does not intersect plane A-A) provides fluid communication between the third port 30 and the fourth port 40 .
  • FIG. 15 illustrates a cross-sectional side view of the five-way high pressure stopcock 110 along line X-X of FIG. 12 . As shown in FIG.
  • FIG. 16 illustrates a cross-sectional bottom view of the five-way high pressure stopcock 110 along line B-B of FIG. 12 .
  • the first fluid path 150 provides fluid communication between the first port 10 and the second port 20 (note that the first fluid path 150 is shown in dashed lines near the second port 20 where its diagonal nature leaves plane B-B).
  • the second fluid path 160 provides fluid communication between the third port 30 and the fourth port 40 .
  • the valve element 140 may likewise be generally cylindrical in shape and may be slidable relative to the valve housing 130 along a longitudinal axis relative to the valve housing 130 .
  • the valve element 140 may form a fluid tight seal relative to the valve housing 130 via one or more O-rings 116 or elastomeric seals arranged between the valve element 140 and the valve housing 130 , for example along the valve element 140 and between the various ports.
  • the one or more O-rings 116 allow the linear stopcock 110 to more readily withstand the high fluid pressures associated with an angiographic injection procedure because the pressures are balanced on each side of the one or more O-rings 116 .
  • the first port 10 configured for connection to the syringe 12 may be provided on (e.g. integrally formed with) a proximal end of the valve element 140 , such that the first port 10 moves relative to the other ports (i.e. the second port 20 , the third port 30 , the fourth port 40 , and the fifth port 50 ) when the valve housing 130 is moved relative to the valve element 140 . Further, the first port 10 may be in constant fluid communication with the first fluid path 150 due to the first port being a part of the valve element 140 .
  • the air detection region 120 may also be provided directly on, or comprise a portion of, the proximal end of the valve element 140 .
  • first fluid path 150 and the second fluid path 160 are defined in the valve element 140 . At least portions of the first fluid path 150 and the second fluid path 160 path may extend parallel to and/or coaxial with a longitudinal axis of the valve element 140 . Further, portions of the first fluid path 150 and the second fluid path 160 extend out of the valve element 140 into the valve housing 130 for communication with the various ports depending on the position of the valve housing 130 and ports relative to the valve element 140 and the corresponding fluid paths 150 , 160 . As with the embodiments of FIGS.
  • the actuator 300 may be an electromechanical motor, such as a solenoid, a rotating ball-screw motor, or other electromechanical motor.
  • the actuator 300 may further include an electromechanical clutch 330 that engages a motor drive assembly 315 with the slidable valve housing 130 and allows the motor to slidably control the valve housing 130 and move the high-pressure linear stopcock 110 between the fill, delivery, full stop, and intermediate stop positions.
  • the electromechanical clutch 330 is in operable communication with the controller 400 and is configured to disengage the motor drive assembly 315 from the slidable valve housing 130 when air is detected in the air detection region 120 by the air detector 200 .
  • the motor drive assembly 315 may actuate the motor drive assembly 315 to move to the full stop position upon detection of one or more air bubbles in air detection region 120 .
  • the valve housing 130 may be in a maximum distal position relative to the valve element 140 .
  • the valve housing 130 is slid relative to the valve element 140 such that the first port 10 is in fluid communication with the fifth port 50 via the first fluid path 150 .
  • the syringe 12 is in fluid communication with the bulk fluid container line 22 such that the syringe 12 can draw fluid from the bulk fluid container 21 (see FIGS. 2 - 6 ).
  • the second port 20 may be isolated such that no flow into or out of the proximal end of the fluid path length 135 is possible.
  • the third port 30 may be in fluid communication with the fourth port 40 due to valve housing 130 being in a distalmost position relative to the valve element 140 .
  • the various ports may be configured so that the third port 30 is not in fluid communication with the fourth port 40 , when in the fill position.
  • the intermediate stop position may allow pre-pressurization of a medical fluid in syringe 12 prior to moving the high-pressure linear stopcock 110 to the delivery position.
  • This may have the advantage of taking up capacitance in the syringe and components and/or taking up mechanical slack in the injector system to provide a more accurate fluid delivery volume as described herein.
  • pre-pressurization of a medical fluid in syringe 12 may provide smoother pressure/flow transitions when switching between injection of a more viscous medical fluid and a less viscous medical fluid, such as contrast and saline, respectively. Examples of injection protocols using pre-pressurization to prevent fluid flow spikes during fluid transitions are described in International PCT Publication Nos.
  • the intermediate stop position may allow for detection of air within the syringe system by pressurization of the syringe contents prior to the injection protocol, as described in International PCT Publication No. WO 2019/204605 entirety.
  • the intermediate stop position may allow for vacuum coalescences and purging of air bubbles from the syringe system prior to the injection protocol, as described in International PCT Publication No. WO 2019/204617.
  • the syringe 12 is in fluid communication with proximal end of the fluid path length 135 .
  • the third port 30 is in fluid communication with the fourth port 40 via the second fluid path, such that the distal end of the fluid path length 135 is in fluid communication with the patient line 55 .
  • fluid injected from the syringe 12 may flow in sequence to the first port 10 , the second port 20 via the first fluid path 150 , the proximal end of the fluid path length 135 connected to the second port 20 , the third port 30 via the fluid path length 135 , the fourth port 40 via the second fluid path 160 , and finally to the patient line 55 .
  • fluid may flow from the syringe 12 to the patient fluid line 55 over the course of an injection protocol until the total desired volume of medical fluid is delivered to the patient or until at least one air bubble is detected in the upstream air detection region 120 , as described herein.
  • the fifth port 50 and consequently the fluid container line 22 , are isolated from the other ports.
  • the full stop position of the high-pressure linear stopcock 110 is illustrated according to an embodiment of the present disclosure.
  • the valve housing 130 may be slid to a maximum proximal position relative to the valve element 140 .
  • the valve housing 130 is moved to a position relative to the valve element 140 such that fluid communication between the fluid path length 135 through the port 30 into the patient line 55 is stopped, thereby preventing further fluid flow and potential delivery of one or more air bubbles to the patient.
  • the valve housing 130 is moved to the full stop position by disengaging the electromechanical clutch 330 from the motor drive assembly 315 , allowing the biasing force from biasing member 310 to slide the valve housing 130 to the full stop position.
  • disengagement of the clutch 330 is activated by the controller 400 upon detection by the air detector 200 of at least one air bubble in the air detection region 120 .
  • FIGS. 24 - 26 an embodiment of a high-pressure linear stopcock 610 that is not connected to other injector or disposable features is shown.
  • the high-pressure linear stopcock 610 of FIGS. 24 - 26 may be functionally similar or identical to the high-pressure linear stopcock 110 of FIGS. 17 - 23 .
  • the high-pressure linear stopcock 610 does not include the actuator 300 , the fluid path length 135 , and other fluid path components that form a part of the high-pressure linear stopcock 110 .
  • the high-pressure linear stopcock 610 includes a valve housing 630 that is rapidly movable relative to a valve element 640 , in the same manner as the valve housing 130 and the valve element 140 of the high-pressure linear stopcock 110 .
  • the high-pressure linear stopcock 610 includes a first port 611 configured for connection to a syringe (not shown); a second port 612 configured for connection to a proximal end of an fluid path length, such as a length of tubing (not shown); a third port 613 configured for connection to a distal end of the fluid path length; a fourth port 614 configured for connection to a patient line (not shown), and a fifth port 615 configured for connection to a bulk fluid container (not shown).
  • the ports 611 , 612 , 613 , 614 , and 615 may be arranged on the high-pressure linear stopcock 610 and may function similarly or identical to the plurality of ports 10 , 20 , 30 , 40 , and 50 , respectively, of the high-pressure linear stopcock 110 .
  • Each of ports 611 , 612 , 613 , 614 , and 615 may be in the form of a connector, such as a Luer connector, a bayonet connector, or the like, to facilitate connection to their associated fluid path components.
  • Other connector designs suitable for use on the various fluid path components are described in PCT International Application No. PCT/US2021/018523, the disclosure of which is incorporated by this reference in its entirety.
  • FIG. 25 illustrates an end-on view of the distal end of the high-pressure linear stopcock 610 , showing the fourth port 614 and the third port 613 .
  • FIG. 26 is a cross-section view along line C-C of FIG. 25 .
  • the high-pressure linear stopcock 610 is attachable to the distal end of a syringe 12 of a high-pressure fluid injector, such as shown in FIG. 1 .
  • the syringe 12 may be connected to the first port 611 of the high-pressure linear stopcock 610 .
  • the high-pressure linear stopcock 610 includes an air detection region 620 at the proximal portion of the high-pressure linear stopcock 610 , analogous to the air detection region 120 of the high-pressure linear stopcock 110 and configured to be placed in operative communication with air detector 200 as described herein.
  • the valve element 640 of the high-pressure linear stopcock 610 may be substantially identical to the valve element 140 of the high-pressure linear stopcock 110 .
  • the valve element 640 may define a first fluid path 650 and a second fluid path 660 that provide selective fluid communication between the ports 611 , 612 , 613 , 614 , and 615 .
  • One or more O-rings 616 provide a fluid tight seal between the valve element 640 and the valve housing 630 while allowing the valve housing 630 to slide relative to the valve element 640 .
  • the valve housing 630 may slide whereas the valve element 640 is held substantially stationary.
  • the high-pressure linear stopcock 110 moves between the fill position, the intermediate stop position, the delivery position, and the full stop position in essentially the same manner as the high-pressure linear stopcock 110 of FIGS. 17 - 23 .
  • the valve element 640 may slide whereas the valve housing 630 is held substantially stationary.
  • the high-pressure linear stopcock 610 may be activated by an actuator 300 in operative communication with a controller 400 in the same manner described in connection with the high-pressure linear stopcock 610 . That is, the high-pressure linear stopcock 610 is operated by an actuator 300 and a biasing member 310 , such as a valve spring, which is biased to the full stop position but can be held one in any of the fill position, the delivery position, or the intermediate stop position by the actuator 300 . Disengaging an electromechanical clutch 330 from a motor drive assembly 315 of the actuator releases the biasing member 310 which then rapidly moves the high-pressure linear stopcock 610 to the full stop position, shutting off fluid flow from the fluid path length 135 and the patient line 55 .
  • a biasing member 310 such as a valve spring
  • FIGS. 27 and 28 illustrate an embodiment of the high-pressure linear stopcock 110 similar to that of FIGS. 17 to 26 , but in which the fluid path length 135 at least partially circumferentially surrounds the valve housing 130 .
  • the fluid path length 135 may be a fluid path element 720 having a cylindrical zig-zag fluid path 730 .
  • the fluid path element 720 may be configured to surround the valve housing 130 in a cylindrical manner or other shape, such as a rectangular box-like structure, conical arrangement, etc.
  • the two end caps 760 may be configured to be bonded to opposite open ends of the tubing bundle 750 .
  • each of the bent fluid channels 765 may direct fluid flow from an end of one of the longitudinal fluid channels 755 to an adjacent longitudinal fluid channel 755 of the bundle 750 , creating the cylindrical zig-zag fluid path 730 .
  • Each end cap 760 may be bonded to opposite ends of the tubing portion 750 , for example, by adhesion, welding, solvent welding, laser welding, and the like.
  • the plurality of longitudinal fluid channels 755 of the fluid path element 720 may be substantially straight and parallel to one another, whereas in other embodiments, the longitudinal fluid channels 755 may be in a configuration that is not parallel but nevertheless reduces the overall footprint of the fluid path element 720 .
  • the fluid path length 135 may be a hollow cylinder 770 wrapped around the valve housing 130 and defining an internal chamber 772 .
  • a cross section of the internal chamber 772 may be annular or ring shaped with the valve housing 130 extending through the center of the internal chamber 772 .
  • the internal chamber 772 may be in fluid communication with the second port 20 and the third port 30 , in essentially the same manner as the tubing bindle 750 of FIGS. 27 - 28 .
  • the internal chamber 772 may have a total volume greater than a volume that an air bubble can travel or expand in the actuation time of the high pressure linear stopcock 110 .
  • the internal chamber 772 may have a total volume of between approximately 2.8 mL and approximately 3.6 mL, and in specific embodiments approximately 3.2 mL. Air bubbles detected by air detector 200 in the air detection region 120 are thus contained in the internal chamber 772 while the high pressure linear stopcock 110 is actuated from the delivery position to the full stop position (or to the intermediate stop position), thereby preventing the air bubbles from reaching the third port 30 and being injected into the patient.
  • the total volume and/or or length of the fluid path length 135 may be a length calculated to ensure that an air bubble detected by the air detector 200 cannot flow or expand through the entirety of the fluid path length 135 in the actuation time taken by high-pressure linear stopcock 110 to reach the stop position.
  • the total length of tubing of the fluid path 730 including all of the longitudinal fluid channels 755 and the bent fluid channels 765 , may be from approximately 1000 millimeters to approximately 1400 millimeters and in specific embodiments may be approximately 1200 millimeters (or from approximately 3.5 to approximately 4.5 feet and in specific embodiments, may be approximately 4 feet).
  • the various fluid path tubing elements may be configured to further reduce a footprint of the tubing between the air bubble sensing region 120 and valve element, for example to reduce the space occupied the tubing in an injection suit, reduce packaging size, increase ease of handling, reduce disposal volume, increase ease of manufacture, etc. while still providing sufficient volume and length to allow actuation of the valve element and prevent further flow of an air bubble into a patient after an upstream air detection event.

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US17/801,975 2020-03-16 2021-03-15 Stopcock apparatus for angiography injector fluid paths Active 2042-12-15 US12427247B2 (en)

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US202062990173P 2020-03-16 2020-03-16
US202062990145P 2020-03-16 2020-03-16
US202062990170P 2020-03-16 2020-03-16
PCT/US2021/022421 WO2021188460A1 (en) 2020-03-16 2021-03-15 Stopcock apparatus for angiography injector fluid paths
US17/801,975 US12427247B2 (en) 2020-03-16 2021-03-15 Stopcock apparatus for angiography injector fluid paths

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CR20220394A (es) 2020-02-21 2023-01-23 Bayer Healthcare Llc Conectores para vía de fluido para suministro de fluidos médicos
IL295599B2 (en) 2020-02-28 2024-09-01 Bayer Healthcare Llc Fluid mixing set
WO2021188460A1 (en) 2020-03-16 2021-09-23 Bayer Healthcare Llc Stopcock apparatus for angiography injector fluid paths
IL299062A (en) 2020-06-18 2023-02-01 Bayer Healthcare Llc Built-in air bubble suspension device for angiography syringe fluid paths
MX2023001722A (es) 2020-08-11 2023-02-22 Bayer Healthcare Llc Caracteristicas para jeringa de angiografia.
EP4255525A2 (de) 2020-12-01 2023-10-11 Bayer HealthCare, LLC Kassette zur halterung von fluidpfadkomponenten für ein fluidinjektorsystem
CA3223779A1 (en) 2021-06-17 2022-12-22 Bayer Healthcare Llc System and method for detecting fluid type in tubing for fluid injector apparatus

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